Methods and devices for cutting and collecting soft tissue

ABSTRACT

Devices and methods for collecting or cutting and collecting a specimen from a mass of tissue within a patient. The device may include a specimen collection assembly including a flexible membrane that isolates collected specimen from the surrounding tissue. The collection device may also include structures that draw the collected specimen toward the shaft and/or otherwise ease the insertion and retraction of the device and the collected specimen from the patient through a small incision.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention pertains to the field of soft tissueexcisional devices and methods. In particular, the present inventionrelates to the field of devices and methods for excising specimen fromsoft tissue, such as breast tissue, for example.

[0003] 2. Description of the Related Art

[0004] Breast cancer is a major threat and concern to women. Earlydetection and treatment of suspicious or cancerous lesions in the breasthas been shown to improve long-term survival of the patient. The trendis, therefore, to encourage women not only to perform monthlyself-breast examination and obtain a yearly breast examination by aqualified physician, but also to undergo annual screening mammographycommencing at age 40. Mammography is the only screening modalityavailable today that can detect small, nonpalpable lesions. Thesenonpalpable lesions may appear as opaque densities relative to normalbreast parenchyma and fat or as clusters of microcalcifications.

[0005] The conventional method for diagnosing, localizing and excisingnonpalpable lesions detected by mammography generally involves atime-consuming, multi-step process. First, the patient goes to theradiology department where the radiologist finds and localizes thelesion either using mammography or ultrasound guidance. Once localized,a radio-opaque wire is inserted into the breast. The distal end of thewire may include a small hook or loop. Ideally, this is placed adjacentto the suspicious area to be biopsied. The patient is then transportedto the operating room. Under general or local anesthesia, the surgeonperforms a procedure called a needle-localized breast biopsy. In theneedle-localized breast biopsy, the surgeon, guided by the wirepreviously placed in the patient's breast, excises a mass of tissuearound the distal end of the wire. The specimen is sent to the radiologydepartment where a specimen radiograph is taken to confirm that thesuspicious lesion is contained within the excised specimen. Meanwhile,the surgeon, patient, anesthesiologist and operating room staff, wait inthe operating room for confirmation of that fact from the radiologistbefore the operation is completed. The suspicious lesion should ideallybe excised in toto with a small margin or rim of normal breast tissue onall sides. Obtaining good margins of normal tissue is extremelydependent upon the skill and experience of the surgeon, and often anexcessively large amount of normal breast tissue is removed to ensurethat the lesion is located within the specimen. This increases the riskof post-operative complications, including bleeding and permanent breastdeformity. As 80% of breast biopsies today are benign, many womenunnecessarily suffer from permanent scarring and deformity from suchbenign breast biopsies.

[0006] More recently, less invasive techniques have been developed tosample or biopsy the suspicious lesions to obtain a histologicaldiagnosis. The simplest of the newer techniques is to attemptvisualization of the lesion by external ultrasound. If seen by externalultrasound, the lesion can be biopsied while being continuouslyvisualized. This technique allows the physician to see the biopsy needleas it actually enters the lesion, thus ensuring that the correct area issampled. Current sampling systems for use with external ultrasoundguidance include a fine needle aspirate, core needle biopsy orvacuum-assisted biopsy devices.

[0007] Another conventional technique localizes the suspicious lesionusing stereotactic digital mammography. The patient is placed prone on aspecial table that includes a hole to allow the designated breast todangle therethrough. The breast is compressed between two mammographyplates, which stabilizes the breast to be biopsied and allows thedigital mammograms to be taken. At least two images are taken at twoangular positions to obtain stereotactic views. The x, y and zcoordinates targeting the lesion are calculated by a computer. Thephysician then aligns a special mechanical stage mounted under the tablethat places the biopsy device into the breast to obtain the sample orsamples. There are believed to be three methods available to biopsylesions using a stereotactic table: (1) fine needle aspiration, (2) coreneedle biopsy and (3) vacuum-assisted core needle biopsy.

[0008] Fine needle aspiration uses a small gauge needle, usually 20 to25 gauge, to aspirate a small sample of cells from the lesion orsuspicious area. The sample is smeared onto slides that are stained andexamined by a cytopathologist. In this technique, individual cells inthe smears are examined, and tissue architecture or histology isgenerally not preserved. Fine needle aspiration is also very dependentupon the skill and experience of the operator and can result in a highnon-diagnostic rate (up to about 83%), due to inadequate samplecollection or preparation.

[0009] Core needle biopsy uses a larger size needle, usually 14 gauge tosample the lesion. Tissue architecture and histology are preserved withthis method. A side-cutting device, consisting of an inner trough withan outer cutting cannula is attached to a spring-loaded device for arapid semi-automated firing action. After the lesion is localized, localanesthetic is instilled and a small incision is made in the skin with ascalpel. The device enters the breast and the needle tip is guided intothe breast up to the targeted lesion. The device is fired. First, theinner cannula containing the trough rapidly penetrates the lesion.Immediately following this, the outer cutting cannula rapidly advancesover the inner cannula cutting a sample of tissue off in the trough. Thewhole device is then removed and the sample retrieved. Multiplepenetrations of the core needle through the breast and into the lesionare required to obtain an adequate sampling of the lesion. Over 10samples have been recommended by some.

[0010] The vacuum-assisted breast biopsy system is a largersemi-automated side-cutting device. It is usually 11 gauge in diameterand is more sophisticated than the core needle biopsy device. Multiplelarge samples can be obtained from the lesion without having to reinsertthe needle each time. A vacuum is added to suck the tissue into thetrough. The rapid firing action of the spring-loaded core needle deviceis replaced with an oscillating outer cannula that cuts the breasttissue off in the trough. The physician controls the speed at which theouter cannula advances over the trough and can rotate the alignment ofthe trough in a clockwise fashion to obtain multiple samples.

[0011] If a fine needle aspirate, needle core biopsy or vacuum-assistedbiopsy shows malignancy or a specific benign diagnosis of atypicalhyperplasia, then the patient needs to undergo another procedure, thetraditional needle-localized breast biopsy, to fully excise the areawith an adequate margin of normal breast tissue. Sometimes thevacuum-assisted device removes the whole targeted lesion. If thisoccurs, a small titanium clip should be placed in the biopsy field. Thisclip marks the area if a needle-localized breast biopsy is subsequentlyrequired for the previously mentioned reasons.

[0012] Another method of biopsying the suspicious lesion utilizes alarge end-cutting core device measuring 0.5 cm to 2.0 cm in diameter.This also uses the stereotactic table for stabilization andlocalization. After the lesion coordinates are calculated and localanesthesia instilled, an incision large enough is permit entry of thebore is made at the entry site with a scalpel. The breast tissue iscored down to and past the lesion. Once the specimen is retrieved, thepatient is turned onto her back and the surgeon cauterizes bleedingvessels under direct vision. The incision, measuring 0.5 to larger than2.0 cm is sutured closed.

[0013] The stereotactic table requires awkward positioning of thepatient and may be extremely uncomfortable. The woman must lie proneduring the entire procedure, which may be impossible for some patients.In addition, the lesion to be biopsied must be in the center workingarea of the mammography plates. This may be extremely difficult anduncomfortable for the patient if the lesion is very posterior near thechest wall or high towards the axilla.

[0014] The woman is subjected to increased radiation exposure asmultiple radiographs are required throughout the course of the procedureto: (1) confirm that the lesion is within the working area of themammography plates, (2) obtain the stereotactic coordinates (at leasttwo views), (3) verify the positioning of the biopsy needle prior toobtaining tissue, and (4) verify that the lesion was indeed sampled. Ifany difficulty is encountered during the procedure, additionalradiographic exposures are required to verify correction of the problem.

[0015] Using the core needle biopsy or vacuum-assisted device, bleedingis controlled only by manual pressure. Bleeding is generally not anissue with fine needle aspiration, but is a legitimate complication ofthe former two methods. Ecchymoses, breast edema and hematomas canoccur. This causes increased post-procedural pain and delays healing.Rarely, the patient may require an emergency operation to control andevacuate a tense hematoma.

[0016] Another major concern is the possibility of tumor dissemination.The core needle biopsy and vacuum-assisted devices both cut into thetumor and carve out multiple samples for examination. While cutting intothe tumor, cancerous cells may be dislodged. Cutting across bloodvessels at the same time may allow the freed cancerous cells access tothe blood stream, thus possibly seeding the tumor beyond its originallocus. The long-term consequences of tumor seeding with the risk ofblood borne metastases are unknown at this time, as the techniques arerelatively new. However, documented instances of cancerous cells seedinglocally into needle tracks exist. There are numerous reports ofmetastases growing in needle tracks from previous biopsies of acancerous mass. Most of these are from lung or liver cancers. However,at least one case of mucinous carcinoma of the breast growing in aneedle track has been reported. The long-term consequences of neoplasmseeding into needle tracks are currently unknown, again because thetechniques are relatively new. Some recommend excision of the entireneedle track, including the skin entry site, during the definitivesurgical procedure for a diagnosed cancer, whether it is a lumpectomy ora mastectomy. Others assume that with a lumpectomy, the post-operativeradiation therapy will destroy any displaced cancer cells in the needletrack. With the trend towards treating very small cancers only byexcision and without a post-excision course of radiation therapy, therisk of cancer cells metastasizing and growing in needle tracks is veryreal.

[0017] The large core cutting device (0.5 cm to 2.0 cm) generallyeliminates the risk of needle track seeding as it is designed to excisethe lesion intact. A stereotactic table is required with the sameinherent awkwardness for the patient, as discussed above. Bleeding iscontrolled, albeit manually, requiring that the patient wait until theend of the procedure to be turned over. Compression is used to stabilizethe breast and localize the lesions. The breast, however, may be torquedand distorted between the compression plates such that when the platesare removed after the biopsy, the large core track left behind may notbe straight, but actually tortuous. This can result in permanent breastdeformity.

[0018] The location of the insertion site into the breast is dictated bythe positioning of the breast in the machine and not by the physician.The entry site is usually away from the cosmetically preferrednipple-areolar complex and is usually located on the more exposed areasof the breast. For the fine needle aspirate, core biopsy andvacuum-assisted devices, the incision is usually very small and the scaralmost unappreciable. However, in the case of the large core biopsydevice (0.5 to 2.0 cm), a large incision is needed. Such a largeincision often results in a non-aesthetically placed scar.

[0019] The newer conventional minimally invasive breast biopsy deviceshave improved in some ways the ability to diagnose mammographicallydetected nonpalpable lesions. These devices give the patient a choice asto how she wants the diagnosis to be made. Moreover, these devices aresubstantially less expensive than the older traditional needle-localizedbreast biopsy. They are not, however, the final solution. Due to theabove-discussed problems and risks associated with compression,needle-track seeding, blood borne metastases, bleeding, radiationexposure and awkwardness of the stereotactic table, more refined devicesand methods are needed to resolve these issues. Also, the conventionalbiopsy devices do not consider margins in their excisions and if canceris diagnosed, the patient must undergo a needle-localized breastlumpectomy to ensure that adequate margins are removed around thecancer. Devices and methods, therefore, must address the problem ofobtaining adequate margins so that a second procedure is not required.Margins, moreover, cannot be assessed while the breast is beingcompressed.

[0020] Commonly assigned U.S. Pat. No. 6,022,362 discloses a novelapproach to soft tissue excisional devices. As disclosed therein, theexcisional device includes independently actuable cutting and collectiontools. As shown therein, the device may include a cutting tool attachednear the distal tip of the device. At least a distal portion of thecutting tool is configured to selectively bow out of the window and toretract within the window. One embodiment of the device described inthis patent also includes an independently actuable tissue collectiondevice that is separate from the cutting device and that is alsoexternally attached near the distal end of the device. In thisconfiguration, the tissue collection device independently collects thetissue severed by the cutting tool as the excisional is rotated and thecutting tool is independently bowed.

[0021] Such a device may tissue cut and collect relatively largespecimens. Once collected, the specimen must be removed from the mass oftissue from which it was excised and must also be removed from thepatient. This presence of such a collected specimen may createnon-insignificant drag on the device as the physician retracts thedevice from the patient. The type of tissue may also affect the easewith which the device and collected specimen may be removed from thepatient. For example, fibrous tissue may make both insertion andretraction of the device more difficult than they would otherwise be thecase in fatty or highly vascularized tissue. Moreover, such a device mayalso cut and collect specimens that are larger than the percutaneousincision (preferably 1 cm or less in length) in which the device isinserted. What are needed, therefore, are means for easing insertion andretraction of the device and its collected specimen from its environmentof use.

SUMMARY OF THE INVENTION

[0022] According to an embodiment thereof, the present invention is adevice for collecting a specimen from a mass of tissue, comprising: ashaft defining a proximal end and a distal end; a specimen collectionassembly disposed near the distal end, the specimen collection assemblyincluding a flexible membrane configured to collect the specimen; aspecimen management assembly, the specimen management assembly beingcoupled to the specimen collection assembly and configured to draw thespecimen collected in the flexible membrane toward the shaft.

[0023] The flexible membrane may be configured to isolate the collectedspecimen from a mass of tissue surrounding the specimen. The specimenmanagement assembly may be coupled to the flexible membrane. Thespecimen management assembly may be configured to selectively pull onthe flexible membrane in at least one direction parallel to the shaft.The specimen management assembly may be configured to selectively pullon the flexible membrane both toward the distal end of the shaft andtoward the proximal end of the shaft. The specimen management assemblymay be configured to selectively pull on the flexible membrane onlytoward the distal end of the shaft. The specimen management assembly maybe configured to selectively pull on the flexible membrane only towardthe proximal end of the shaft. A portion of the flexible membrane may beattached to the distal end of the shaft. The specimen managementassembly may include at least one wire coupled to the flexible membrane.The wire(s) may be configured to selectively pull on the flexiblemembrane in at least one direction that may be parallel to the shaft.The wire(s) may be configured to selectively pull on the flexiblemembrane both toward the distal end of the shaft and toward the proximalend of the shaft. The wire may be configured to selectively pull on theflexible membrane only toward the distal end of the shaft. The wire(s)may be configured to selectively pull on the flexible membrane onlytoward the proximal end of the shaft. A portion of the flexible membranemay be secured to the distal end of the shaft. The device may alsoinclude a specimen cutting assembly, the specimen cutting assembly beingconfigured to cut the specimen from a mass of tissue.

[0024] The present invention may also be viewed as a method ofcollecting a specimen from a mass of tissue, comprising the steps ofproviding a tissue collection device comprising a shaft having aproximal and a distal end; a specimen collection assembly disposed nearthe distal end, the specimen collection assembly including a flexiblemembrane configured to collect the specimen; inserting the tissuecollection device within the mass of tissue; collecting the specimenwithin the flexible membrane, and drawing the flexible membrane and thecollected specimen toward the shaft.

[0025] A step may be carried out of retracting the tissue collectiondevice from the mass of tissue with the specimen collected within theflexible membrane and drawn toward the shaft. The tissue collectiondevice in the providing step may include a specimen management assemblycoupled to the flexible membrane and the drawing step may be carried outby acting on the specimen management assembly. The specimen managementassembly may include at least one wire attached to the flexiblemembrane. The collecting step may isolate the collected specimen from amass of tissue surrounding the specimen. The drawing step mayselectively pull on the flexible membrane in at least one directionparallel to the shaft. The drawing step may selectively pull on theflexible membrane both toward the distal end of the shaft and toward theproximal end of the shaft. The drawing step may selectively pull on theflexible membrane only toward the distal end of the shaft.Alternatively, the drawing step may selectively pull on the flexiblemembrane only toward the proximal end of the shaft. The specimenmanagement assembly may include at least one wire coupled to theflexible membrane and the drawing step may include pulling on the atleast one wire. The drawing step may include pulling on the at least onewire in at least one direction parallel to the shaft. The drawing stepmay include pulling on the at least one wire both toward the distal endof the shaft and toward the proximal end of the shaft. The drawing stepmay include pulling on the at least one wire only toward the distal endof the shaft. The drawing step may include pulling on the at least onewire only toward the proximal end of the shaft. The tissue collectiondevice in the providing step further may include a specimen cuttingassembly and the method further may include a step of acting upon thespecimen cutting assembly to cut the specimen from the mass of tissue.The providing step may provide the tissue collection device with thespecimen cutting assembly coupled to the specimen collection assembly.

[0026] The present invention, according to another embodiment thereofmay be viewed as a device for collecting a specimen from a mass oftissue, comprising: a shaft; a specimen collection assembly configuredto slide between the proximal and distal ends of the shaft and toselectively assume an expanded configuration and a retractedconfiguration, the specimen collection assembly including a flexiblemembrane configured to collect the specimen and to isolate the collectedspecimen from the mass of tissue.

[0027] A portion of the flexible membrane may be attached to the distalend of the shaft. The specimen collection assembly may include a cuttingportion for cutting the specimen from a surrounding tissue. The flexiblemembrane may be configured to isolate the collected specimen from themass of tissue. The shaft may define a proximal and a distal end and achannel between the proximal and distal ends and the specimen collectionassembly may be configured to slide within the channel between theproximal and distal ends of the shaft. The shaft may define a proximaland a distal end and comprises a rail between the proximal and distalends and the specimen collection assembly may be configured to slide onthe rail between the proximal and distal ends of the shaft.

[0028] According to yet another embodiment thereof, the presentinvention is a method of collecting a specimen from a mass of tissue,comprising the steps of providing a tissue collection device comprisinga shaft and a specimen collection assembly, the shaft defining aproximal and a distal end, the specimen collection assembly beingconfigured to slide between the proximal and distal ends and toselectively expand away from the shaft and to contract toward the shaft,the specimen collection assembly including a flexible membraneconfigured to collect the specimen; inserting the tissue collectiondevice within the mass of tissue; expanding the specimen collectionassembly and collecting the specimen within the flexible membrane;retracting the specimen collection assembly with the specimen collectedwithin the flexible membrane; sliding the retracted specimen collectionassembly toward the proximal end of the shaft with the specimencollected within the flexible membrane.

[0029] The tissue collection device in the providing step may include atissue cutting portion to cut the specimen from the mass of tissue. Thecollecting step may collect the specimen cut from the cutting portion.The method may also include a step of sliding the specimen collectionassembly toward the distal end of the shaft before the inserting step.In the inserting step, the tissue collection device may be in aconfiguration in which the specimen collection assembly may be slidtoward the distal end of the shaft. The method may further include astep of sliding the specimen collection assembly toward the distal endof the shaft before the expanding and collecting steps. The tissuecollection device in the providing step may be configured such that aportion of the flexible membrane may be attached to the distal end ofthe shaft, and the sliding step draws the specimen collected within theflexible membrane toward the shaft. The method may also include a stepof retracting the tissue collection device from the mass of tissue withthe specimen collection assembly near the proximal end of the shaft andthe specimen collected within the flexible membrane. The retracting stepmay isolate the specimen collected within the flexible membrane from themass of tissue. In the providing step, the shaft may define a channelbetween the proximal and distal ends of the shaft and the sliding stepmay slide the retracted specimen collection assembly within the channel.In the providing step, the shaft may include a rail between the proximaland distal ends of the shaft and the sliding step slides the retractedspecimen collection assembly on the rail.

[0030] The present invention, according to yet another embodimentthereof, is a method of collecting a specimen from a mass of tissue,comprising the steps of providing a tissue collection device comprisinga shaft defining a proximal and a distal end, a sleeve disposed over atleast a portion of the shaft and a specimen collection assemblyconfigured to selectively expand away from the shaft and to retracttoward the shaft and including a flexible membrane configured to collectthe specimen, at least a portion of the flexible membrane being disposedbetween the shaft and the sleeve; inserting the tissue collection devicewithin the mass of tissue; expanding the specimen collection assemblyand collecting the specimen within the flexible membrane, the expandingspecimen collection assembly pulling the flexible membrane out frombetween the shaft and the sleeve, and retracting the specimen collectionassembly with the specimen collected within the flexible membrane.

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] For a further understanding of the objects and advantages of thepresent invention, reference should be made to the following detaileddescription, taken in conjunction with the accompanying figures, inwhich:

[0032]FIG. 1A is perspective view of an excisional device according toan embodiment of the present invention.

[0033]FIG. 1B is a partial enlarged view of the excisional device ofFIG. 1A, in which the integrated cut and collect assembly thereof is inan expanded configuration.

[0034]FIG. 2A is a cross-sectional side view of an excisional deviceaccording to an embodiment of the present invention.

[0035]FIG. 2B is a perspective view of a portion of the integrated cutand collect assembly of FIG. 2A.

[0036]FIG. 2C is a perspective view of the collection portion of theintegrated cut and collect assembly, showing the manner in which theflexible membrane may be attached to the assembly and the outer surfaceof the shaft of the present excisional device, according to anembodiment of the present invention.

[0037]FIG. 2D is a perspective view of a shaft of the present excisionaldevice, showing further aspects of the present invention.

[0038]FIG. 3 is a perspective view of an excisional device according toan embodiment of the present invention, with the integrated cut andcollect assembly in the retracted position.

[0039]FIG. 4 shows the excisional device of FIG. 3, with the integratedcut and collect assembly in an expanded position.

[0040]FIG. 5 shows the excisional device of FIG. 3, with the integratedcut and collect assembly in a fully expanded position.

[0041]FIG. 6 shows an exemplary configuration of the integrated cut andcollect assembly of the present invention, detailing the manner in whichthe collecting portion may be attached to the cutting portion of theintegrated cut and collect assembly.

[0042]FIG. 7 shows another exemplary configuration of the integrated cutand collect assembly of the present invention.

[0043]FIG. 8A shows yet another exemplary configuration of theintegrated cut and collect assembly of the present invention, detailingthe manner in which the collecting portion may be attached to thecutting portion of the integrated cut and collect assembly.

[0044]FIG. 8B shows still another exemplary configuration of theintegrated cut and collect assembly of the present invention, detailingthe manner in which the collecting portion may be attached to thecutting portion of the integrated cut and collect assembly.

[0045]FIG. 8C shows a perspective and a cross sectional view of stillanother exemplary configuration of the integrated cut and collectassembly of the present invention.

[0046]FIG. 8D shows yet another exemplary configuration of theintegrated cut and collect assembly of the present invention, detailingthe manner in which the collecting portion may be attached to thecutting portion of the integrated cut and collect assembly.

[0047]FIG. 8E shows a still further exemplary configuration of theintegrated cut and collect assembly of the present invention.

[0048]FIG. 9 illustrates aspects of the present method for cutting andcollecting a tissue specimen from a mass of tissue, according to anembodiment of the present invention.

[0049]FIG. 10 illustrates further aspects of the present method forcutting and collecting a tissue specimen from a mass of tissue,according to an embodiment of the present invention.

[0050]FIG. 11 illustrates still further aspects of the present methodfor cutting and collecting a tissue specimen from a mass of tissue,according to an embodiment of the present invention.

[0051]FIG. 12 illustrates further aspects of the present method forcutting and collecting a tissue specimen from a mass of tissue,according to an embodiment of the present invention.

[0052]FIG. 13 illustrates further aspects of the present method forcutting and collecting a tissue specimen from a mass of tissue,according to an embodiment of the present invention.

[0053]FIG. 14 illustrates further aspects of the present method forcutting and collecting a tissue specimen from a mass of tissue,according to an embodiment of the present invention in which thecollected and isolated (encapsulated) tissue specimen trails the distaltip of the excisional device as it is retracted from the tissue.

[0054]FIG. 15 illustrates further aspects of the present method forcutting and collecting a tissue specimen from a mass of tissue,according to another embodiment of the present invention in which thecollected and isolated tissue specimen trails the distal end of theexcisional device as it is retracted from the tissue.

[0055]FIG. 16 illustrates still further aspects of the present methodfor cutting and collecting a tissue specimen from a mass of tissue, inwhich the excisional device containing the tissue specimen has beenfully removed from the tissue mass from which the specimen was cut,collected and isolated.

[0056]FIG. 17 shows aspects of another embodiment of the presentinvention.

[0057]FIG. 18 shows the embodiment of FIG. 18 in a state in which thecollected specimen is drawn toward the shaft prior to retraction of thedevice.

[0058]FIG. 19 shows aspects of yet another embodiment of the presentinvention.

[0059]FIG. 20 shows the embodiment of FIG. 19 in a state in which thecollected specimen is drawn toward the shaft prior to retraction of thedevice.

[0060]FIG. 21 shows a portion of another embodiment of an excisionaldevice according to the present invention.

[0061]FIG. 22 shows further aspects of the embodiment of FIG. 21.

[0062]FIG. 23 shows still further aspects of the embodiment of FIG. 21.

[0063]FIG. 24 is a perspective view of a distal portion of the shaft ofan excisional device in a first configuration, according to a sillfurther embodiment of the present invention.

[0064]FIG. 25 shows the embodiment of FIG. 24, with the shaftrepresented in phantom lines to reveal further structural aspectsthereof.

[0065]FIG. 26 shows a perspective view of the embodiment of FIG. 24 in asecond configuration.

[0066]FIG. 27 shows the embodiment of FIG. 26, with the shaftrepresented in phantom lines to reveal further structural aspectsthereof.

[0067]FIG. 28 is a cross-sectional view of another embodiment of thepresent invention in which at least a portion of the shaft of thepresent excisional device is covered by a sleeve, to ease the insertionand/or retraction of the present excisional device into and from a massof tissue.

[0068]FIG. 29 is a cross-sectional view of the embodiment of FIG. 28,with the tissue collection assembly of the present excisional device inan expanded configuration.

DESCRIPTION OF THE INVENTION

[0069]FIG. 1A is a perspective view of an excisional device according toan embodiment of the present invention. As shown, the excisional device100 includes a proximal section 102 that may be configured to fit thephysician's hand. Extending from the proximal section 102 is a shaft 104that may be terminated by a distal tip 106. However, an introducer maybe used for the initial incision, whereupon the tip 106 may be omittedfrom the device 100. The distal tip 106 is configured so as to easilypenetrate a mass of tissue, and may feature curvilinear cutting surfaces(best seen in FIG. 1B). The distal tip 106 may be configured to beenergized by a radio frequency (RF) energy source, supplied via theelectrical cord 122. However, the distal tip 106 need not be energized,as the sharpness of the cutting surfaces of the distal tip 106 isgenerally sufficient to easily penetrate the tissue to the targetexcision site. The distal tip 106 may be configured to be retractableand extendable, so as to reduce trauma, as disclosed in commonlyassigned U.S. patent application Ser. No. 10/290,051, filed on Nov. 6,2002, attorney docket number RUBI5814, the disclosure of which isincorporated herein in its entirety. An integrated cut and collectassembly 108 is mounted near the distal tip 106 or near the distal mostportion of the shaft 104. According to the present invention, theintegrated cutting and collection assembly 108 is configured to cut atissue specimen (a piece of tissue or a lesion) from the mass of tissue(such as, for example, breast tissue), to collect the cut specimen andto isolate the cut specimen from the surrounding tissue by, for example,encapsulating the same within a flexible bag-shaped membrane. Althoughthe present invention finds advantageous utility in terms of excisionalprocedures on the female breast, it is understood that the presentinvention is not limited thereto. Indeed, the present methods anddevices may be advantageously employed and deployed within most any massof soft tissue. Moreover, although the present excisional devicedescribed and shown herein is presented as a hand held excisionaldevice, it is to be understood that the proximal section 102 may besuitably modified to fit within a stereotactic unit for automated,semi-automated or manual operation.

[0070] According to the present invention, the integrated cut andcollect assembly 108 includes a cutting portion and a collection portionthat includes a flexible membrane 114. The collection portion ofintegrated cut and collect assembly 108 is attached to the cuttingportion. As shown most clearly in FIG. 1B, the collection portion may beattached to the cutting portion, according to an embodiment of thepresent invention, by a small ring member 124 encircling both thecutting portion and part of the collecting portion so as to insure thatthe cutting and collection portions of the integrated cut and collectassembly 108 move together. As noted above, the cutting portion isconfigured to cut the specimen from the mass of tissue and thecollection portion is configured to collect the cut specimen and toisolate the cut specimen from surrounding tissue. This isolation fromsurrounding tissue, according to the present invention, is carried outby a flexible membrane 114 that forms a part of the collecting portionof the integrated cut and collect assembly 108, as described in detailbelow.

[0071] The integrated cut and collect assembly 108 may be mechanicallycoupled to an actuator 112 such that operation of the actuator 112causes a deployment of the integrated cut and collect assembly 108 fromthe retracted position shown in FIG. 1A in which the integrated cut andcollect assembly 108 is at least partially retracted within a trough 120defined within the shaft 104 to a selectable expanded position away fromthe shaft 104, as shown in FIG. 1B. For example, by pushing the actuator112 in the distal direction (i.e., toward the distal tip 106), theintegrated cut and collect assembly 108 transitions from the retractedposition shown in FIG. 1A to a selectable variable expanded positionillustrated in FIG. 1B in which the integrated cut and collect assembly108 bows out radially relative to the longitudinal axis of the shaft 104(i.e., in the direction of arrow 110 in FIG. 1A). The degree of bowing(expansion) of the integrated cut and collect assembly 108 depends uponthe travel imposed upon the actuator 112 by the physician. In thismanner, the physician may match the degree of expansion of theintegrated cut and collect assembly 108 to the size of the targetedlesion or the size of the desired specimen within the mass of tissue.The degree of expansion may be varied at will during the excisionalprocedure by means of direct observation by means of ultrasound or someother imaging or guidance modality disposed within the shaft 104 orexternal to the device 100.

[0072] The cutting portion may include a ribbon 116 that is pushed outof the trough 120 to assume the bowed shape of FIG. 1B. The ribbon maybe energized by an RF energy source so as to efficiently cut thespecimen from the mass of tissue. A standard, off the shelf and widelyavailable RF generator, such as a ValleyLab Force FX Generator fromValleyLab of Boulder, Colo. may advantageously be used to energize thecutting portion of the integrated cut and collect assembly 108 of thepresent invention, although other RF generators may also be employed toenergize the cutting portion of the integrated cut and collect assembly108 and/or the tip 106 described herein. As the excisional device isrotated during the cutting of the specimen, the ribbon 116 of thecutting portion preferably forms the leading edge of the integrated cutand collect assembly 108. The collecting portion of the integrated cutand collect assembly 108 may also include a ribbon that is mechanicallycoupled to the cutting portion thereof, shown in FIG. 1B at referencenumeral 118. The ribbon 118 of the collecting portion may at leastpartially overlap the ribbon 116 of the cutting portion. Attached to thecollecting ribbon 118 and/or to the ribbon 116 of the cutting portion isa flexible membrane 114, which serves to collect and to isolate thecollected specimen by drawing over the cut specimen and encapsulatingsame. The flexible membrane 114 may be shaped as a bag (a container thatis closed on all sides except a selectively openable and closableopening) whose opening may be attached to both the shaft 104 and thecollecting ribbon 118 and/or the ribbon 116 of the cutting portion ofthe integrated cut and collect assembly 108. Although the embodiment ofthe present invention shown in FIGS. 1A and 1B includes a cutting ribbon116 and a collecting ribbon 118, both ribbons are expanded and retractedsubstantially simultaneously as they are mechanically coupled to oneanother to form the integrated cut and collect assembly 108, a singlemechanical expandable and retractable loop. Alternatively, only a singleribbon may be present and the flexible membrane attached directly tosuch single ribbon, as detailed herein below. By virtue of thisconfiguration, when the integrated cut and collect assembly 108 is inthe expanded position (FIG. 1B), the bag is in an open configuration inwhich the tissue cut by the cutting portion is received and collected inthe bag formed by the flexible membrane 114 as the device is rotated.However, when the integrated cut and collect assembly 108 is in theretracted position (FIG. 1A), the opening of the bag formed by theflexible membrane 114 is pinched shut or substantially shut, therebytrapping and encapsulating the collected specimen therein and isolating(or substantially isolating) the collected specimen from the surroundingtissue.

[0073]FIG. 2A is a cross-sectional side view of an excisional deviceaccording to an embodiment of the present invention. As shown, theactuator 112 may be mechanically coupled to the integrated cut andcollect assembly 108 so that when the actuator is pushed in the proximaldirection, the integrated cut and collect assembly 108 retracts withinthe trough 120 defined within the shaft 104. Conversely, when theactuator 112 is pushed in the distal direction, the integrated cut andcollect assembly 108 is pushed out of the trough 120 and expands out ofthe trough 120 to assume the bowed shape shown in FIG. 2A. The ribbon orribbons of the integrated cut and collect assembly 108 may extend backto the actuator 112 through a first lumen 204 defined within the shaft104 and may be attached to the actuator 112 to thereby enable movementof the actuator 112 to expand and retract the integrated cut and collectassembly 108. Alternatively, the ribbon 118 of the collecting portion ofthe integrated cut and collect assembly 108 may only extend a fractionof the length of the cutting ribbon 116. However, as the two ribbons aremechanically coupled to one another, expansion of the cutting ribbon 116causes the simultaneous expansion of the collecting ribbon 118 withoutthe collecting ribbon 118 being directly attached to the actuator 112.

[0074] A second lumen 206 may also be defined within the shaft 104. Thesecond lumen 206 may be used, for example, to evacuate smoke and/orbodily fluids from the excision site within the mass of tissue.Alternatively the second lumen 206 defined within the shaft 104 may beused to deliver a pharmaceutical agent to the excisional site, such as,for example, an anesthetic, an analgesic and/or some other agent. Otheruses may be found for such lumen. An inflatable balloon 208 may becoupled to the shaft 104. The balloon 208 may be inflated with, forexample, a gas (air, an inert gas or carbon dioxide, for example) or afluid such as saline. The balloon may serve several functions. Forexample, the balloon 208 may be configured to massage the mass of tissueby pulsating the inflation of the balloon, may be configured as acooling sleeve, may be configured as a tissue expander, may beconfigured to stabilize the device when inserted in tissue, may beconfigured to seal the incision through which the device is inserted, toprovide hemostatis, and/or to reduce capacitive coupling to reducetissue heating. The balloon 208 may be inflated from a lumen definedwithin the excisional device and supplied to the device via a suitableport defined in the proximal end of the device. The actuator 112 maydefine one or more protrusions 212 and an interior surface of the devicemay include corresponding crenelations that are collectively andcooperatively configured to provide a number of set stops to theactuator 112 along its travel path and optionally a tactile feedback forthe physician, who can set the integrated cut and collect assembly 108to predetermined degrees of expansion without looking at the deviceduring the excisional procedure. Indeed, during the procedure, as thephysician expands the integrated cut and collect assembly 108, he or shewill feel periodic increases in resistance followed by a tactile and/oraudible release as the protrusions 212 slip into the crenelations 210.

[0075]FIG. 2B is a perspective view of a detail of the integrated cutand collect assembly 108 of FIG. 2A. According to this embodiment, thecutting ribbon includes a first cutter ribbon 116A and a second cutterribbon 116B that may be welded (or otherwise attached) to the firstcutter ribbon 116A, as shown by weld 252. Together, the first cutterribbon 116A and the second cutter ribbon 116B constitute the leading(and cutting) edge of the integrated cut and collect assembly 108.Behind this leading edge is the collecting portion of the integrated cutand collect assembly 108. Specifically, behind the leading edge of thecutting portion is disposed the ribbon 118 to which the flexiblemembrane 114 is attached. The ribbon 118 to which the flexible membrane114 is attached may also be welded (or otherwise attached) to the firstcutter ribbon 116A, as also shown at 252. The first ribbon 116A may berelatively wider than the second ribbon 116B, so as to completelyoverlap both the second ribbon 116B and the ribbon 118 to which theflexible membrane 114 is attached. This gives the integrated cut andcollect assembly 108 necessary rigidity, while allowing the secondribbon 116B and the ribbon 118 to be reduced in size, thereby reducingspace and bulk. The three ribbons 116A, 116B and 118 are preferably keptat a voltage equipotential, so as to decrease the possibility of arcingwhen RF power is applied to the integrated cut and collect assembly 108.According to an advantageous embodiment of the present invention, onlythe first ribbon 116A need be coupled to the actuator 112. As the secondribbon 116B and the ribbon 118 are mechanically coupled to the firstribbon 116A, they will move in unison with the first ribbon 116A as theactuator 112 is moved by the physician or the stereotactic unit to whichthe device 100 may be coupled.

[0076]FIG. 2C is a perspective view of the collection portion of theintegrated cut and collect assembly, showing the manner in which theflexible membrane 114 may be attached within the assembly 108 and to theouter surface of the shaft 104 of the present excisional device 100,according to an embodiment of the present invention. As shown therein,the flexible membrane 114 may include a lumen forming portion 224through which the ribbon 118 (see FIG. 2B) is inserted, to providerigidity to the mouth or opening 222 of the collecting portion of theintegrated cut and collect assembly 108. The ribbon 118 is attached tothe cutting ribbon 116 (116A, 116B) so as to expand and retracttherewith under the action of the actuator 112. The flexible membrane114 also includes a shaft attachment tab 220, which is configured toattach the flexible membrane 114 to the shaft 104 of the presentexcisional device. For example, the shaft attachment tab 220 may beattached to the shaft 104 through a mechanically and biologicallyappropriate adhesive. The remainder of the flexible membrane 114 may beshaped as a bag, the opening or mouth 222 thereof being delimited by theshaft attachment tab 220 and the lumen forming portion 225 through whichthe ribbon 118 runs. Therefore, when the actuator 112 causes theintegrated cut and collect assembly 108 to expand, the opening 222 ofthe integrated cut and collect assembly 108 is opened and when theactuator 112 causes the integrated cut and collect assembly 108 toretract at least partially within the shaft 104, the mouth 222 of thebag formed by the flexible membrane 114 closes, effectivelyencapsulating and isolating whatever tissue, specimen or lesion has beencut and collected therein. The tissue is isolated, as the lumen formingportion 224, when the integrated cut and collect assembly 108 is in theretracted state, may be pressed against the shaft 104, therebyinterposing a layer of the flexible membrane 114 between the collectedtissue and the surrounding tissue.

[0077] As an alternative, the flexible membrane 114 may be attached toan exterior surface of the device 100 and to a tube defining a lumenrunning at least a portion of the length of the second ribbon 118. Theflexible membrane may be attached thereto by means of an adhesive, forexample. Other means and structures for attaching the flexible membrane114 to the cutting portion of the integrated cut and collect assembly108 are disclosed herein below.

[0078]FIG. 2D is a perspective view of a shaft 104 of the presentexcisional device, showing further aspects thereof. As shown therein,the shaft 104 defines a trough 120 near the distal end thereof.Preferably, the trough 120 includes a ledge portion 121 that is cut outof the shaft 104. The ledge 121 allows additional room to accommodatethe membrane 114 when the integrated cut and collect assembly 108retracts within the trough 120. The ledge 121 within the trough 120enables the integrated cut and collect assembly 108 to more fullyretract within the trough 120 than would otherwise be possible withoutthe ledge 121 by providing additional space for the membrane 114.Without the ledge 121, the bulk of the membrane 114 could hamper thefull retraction of the integrated cut and collect assembly 108 into thetrough 120. The integrated cut and collect assembly 108 is preferably atleast partially retracted within the trough 120 when the cutting portionthereof is first energized, prior to initiating cutting of tissue. Thisseparates the tissue to be cut from the cutting portion of theintegrated cut and collect assembly 108 until the assembly has beensufficiently energized to efficiently cut through the tissue. The trough120 is also instrumental is allowing the present excisional device toutilize a standard RF generator (e.g., one that does not rely uponfeedback from an impedance sensor or the like to vary the appliedpower), such as the ValleyLab Force FX Generator discussed above.Keeping the integrated cut and collect assembly 108 at least partiallyretracted within the trough 120 also prevents excessivethermally-induced tissue damage, as all or most of the surface area ofthe cutting portion of the integrated cut and collect assembly 108 iskept away from the tissue until the cutting portion is fully energized(i.e., until the current density at the cutting portion of theintegrated cut and collect assembly 108 is sufficient to initiate andmaintain arcing). Other means and structures for that find utility inenabling the RF cutting portion of the integrated cut and collectassembly 108 are disclosed in commonly assigned and co-pending U.S.application Ser. No. 09/xxx,xxx filed on xx/xx/xx, the disclosure ofwhich is hereby incorporated herein in its entirety.

[0079]FIGS. 3-5 collectively show the operation of integrated cut andcollect assembly of the present excisional device. As shown in FIG. 3,the actuator 112 is in its proximal most position and the integrated cutand collect assembly 108 mechanically coupled thereto is in thesubstantially retracted position wherein both the cutting and collectingportions thereof are at least partially retracted within through 120defined within the shaft 104. The flexible membrane 114 of thecollecting portion may initially be folded, (at least partially) stowedin the trough 120 defined within the shaft 104, or simply loose. As themembrane 114 is preferably thin, smooth and flexible, it does notsignificantly hamper the insertion of the instrument as it penetratesthe tissue mass. As shown in FIG. 4, sliding the actuator 112 in theproximal direction causes the integrated cut and collect assembly 108 toexpand in the direction shown by arrow 110. This expansion causes thecutting portion of the assembly 108 to bow radially out from the shaft104 and the deployment of the flexible membrane 114 of the collectingportion. As the flexible membrane 114 is attached both to the outersurface of the shaft 104 and to the integrated cut and collect assembly108, expansion of the integrated cut and collect assembly 108 opens themouth of the bag shaped flexible membrane 114 and retraction thereof(FIG. 3) closes the mouth thereof. FIG. 4 shows the device 100 in aconfiguration wherein the actuator 112 is engaged to its distal mostposition and the integrated cut and collect assembly 108 is fullyexpanded. By varying the position of the actuator 112, the physician mayachieve a fined grained control over the deployment of the integratedcut and collect assembly 108 to suit even an irregularly-shaped andsized specimen or lesion to be cut, collected, isolated and retrieved.

[0080] The integrated cut and collect assembly 108, according to thepresent invention, may include one or more mechanically coupled ribbonsor wires. For example, the device 100 may include a first ribbon 116 ofthe cutting portion and a second ribbon 118 to which the flexiblemembrane 114 is attached. Alternatively, the flexible membrane 114 maybe attached to a trailing edge of the ribbon 116 of the cutting portionof the integrated cut and collect assembly 108. In such an embodiment,the integrated cut and collect assembly 108 does not include separatebut mechanically coupled cutting and collecting portions, but insteadincludes only a single ribbon 116 or other (RF) cutting element to whichthe flexible membrane 114 is attached. Other methods and means ofattaching the flexible membrane to the cutting portion are disclosedhereunder. Such methods and means may draw upon the physical mechanicalstructure of the cutting portion, the collecting portion, the ribbon 116and/or 118 and the material of the flexible membrane 114.

[0081]FIG. 6 shows an exemplary configuration of the integrated cut andcollect assembly of the present invention, detailing one possible mannerin which the collecting portion may be attached to the cutting portionof the integrated cut and collect assembly 108. As shown therein, theintegrated cut and collect assembly 108 may include only a single ribbon116. This single ribbon 116 forms the cutting portion of the assembly108. According to this embodiment, the ribbon 116 may be configured as aflexible tube with a longitudinal slit 606 through which the flexiblemembrane 114 emerges. The flexible membrane 114, according to thisembodiment, may include a locally thicker (bulbous, for example) portion602 that is disposed within the interior lumen 608 defined by thetube-shaped ribbon 116. The slit 606 is oriented such that the flexiblemembrane 114 extends out of the trailing edge 612 of the ribbon 116. Asthe ribbon 116 is expanded and energized and the excisional device 100rotated, the leading edge 610 of the ribbon 116 cuts through the tissue,while the flexible membrane 114 is deployed and trails behind,collecting, isolating and encapsulating the cut tissue. The ribbon 116need not be shaped as a tube, but may assume any shape that efficientlycuts through the tissue and secures the flexible membrane 114 thereto.Moreover, the ribbon need not completely encircle the locally thickerportion 602 of the flexible membrane 114. The ribbon 116 may beadvantageously formed of a conductive and resilient material such asstainless steel, titanium, tungsten or a shape memory metal, such as anickel titanium alloy sold under the name of Nitinol®, for example.

[0082] As an alternative to the solid ribbon 116, the cutting portion ofthe integrated cut and collect assembly 108 may include or be formed ofa plurality of wires or ribbons braided in such a manner as to form thetissue cutting ribbon, as shown at 702 in FIG. 7. To provide additionalrigidity, a central reinforcing ribbon or mandrel 704 may be disposedwithin the interior lumen formed by the braided ribbon 702. As shown inFIG. 7, the locally thicker portion 706 of the flexible membrane 114 maybe formed around the central reinforcing ribbon 704.

[0083]FIG. 8A shows another embodiment of the integrated cut and collectassembly 108. As shown, the flexible membrane 114 of the collectingportion may be sandwiched between two flexible plates 806, 808. Rivets,pins and/or welds 808 secure the two plates 804, 806 to one another withthe flexible membrane 114 therebetween. The plates 804, 806 arepreferably sufficiently flexible to selectively assume the retractedshape and the expanded and bowed shape of the integrated cut and collectassembly 108, as shown in FIGS. 3 and 5, respectively. The assembly ofFIG. 8A may also include a solid or braided conductive (shown) ribbon orwire 802. The ribbon 802 may also be sandwiched between the two plates804, 806 and held securely in place. In this case, the ribbon 802defines the leading edge of the integrated cut and collect assembly 108and the flexible membrane 114 the trailing edge thereof. The plates 804,806 and the rivets, welds or pins 808 may be formed of a conductivematerial. In that case, when the ribbon 802 is energized with RF energy,the ribbon 802 and the plates 804, 806 are at a same voltage potential,which prevents or decreases the probability of arcing between the plates804, 806 and the ribbon 802. Alternatively, only the wire or ribbon 802may be formed of a conductive material and the plates 804, 806 and therivets, welds or pins formed of an insulating material. In this case,only then wire or ribbon 802 is energized and cuts through the tissue.

[0084]FIG. 8B shows yet another embodiment of the integrated cut andcollect assembly 108, in which the collecting portion is directlyattached to the cutting portion thereof. As shown therein, the cuttingportion of the integrated cut and collect assembly 108 may include awindowed conductive plate 802. This conductive (metal, for example)plate 820 is preferably a thin plate in which openings 822 are defined.The thin plate 820, according to this embodiment, forms the cuttingportion of the integrated cut and collect assembly 108. This cuttingportion may be formed by bending the plate 820 along the longitudinalaxis 824 to secure the flexible membrane 114 between the free edgesthereof. The leading edge of the integrated cut and collect assembly108, therefore, may be formed by the bent plate 820 whereas the trailingedge thereof includes the flexible membrane 114. The openings 822 in theplate 820 may facilitate the bending thereof, so as to allow theflexible membrane 114 to be securely attached thereto. Crimping of thefree edges of the plate 820 and/or an adhesive may be used to secure theflexible membrane 114 to the plate 820. The windows or openings 822 maybe defined within the plate 820 by stamping, through a photoetchingtechnique or by cutting, as those of skill in this art will recognize.

[0085]FIG. 8C shows a perspective and a cross sectional view of stillanother exemplary configuration of the integrated cut and collectassembly of the present invention. As shown therein, the cutting portionof the integrated cut and collect assembly 108 may be an ellipticalcylinder that defines an interior lumen 853. The cutting portion 852 maybe energized with RF energy, as discussed above. A mandrel 854 may bedisposed within the cutting portion 852. A slot 856 is defined onlywithin the trailing edge 858, and not within the leading (cutting) edge860 of the cutting portion 851 of the integrated cut and collectassembly 108. The flexible membrane 114 loops around the mandrel andemerges from the cutting portion 852 from the slot 856. The flexiblemembrane 114 may be bonded at 862 after looping around the mandrel 854.Alternatively, the mandrel 854 may be inserted in a lumen formed by theflexible membrane 114. As with the other embodiments discussed relativeto FIGS. 6, 7 and 8, the flexible membrane may also be attached to theouter surface of the shaft 104 by means of a tab, such as shown atreference numeral 220 in FIG. 2C, so as to allow the bag-shaped flexiblemembrane 114 to selectively open an close upon being acted upon byactuator 112.

[0086]FIG. 8D shows yet another exemplary configuration of theintegrated cut and collect assembly of the present invention, detailingthe manner in which the collecting portion may be attached to thecutting portion of the integrated cut and collect assembly. As showntherein, the integrated cut and collect assembly 108 may be configuredas a single ribbon 876 that defines a cutting portion 872 and acollecting portion 874. The single ribbon 876 may be split at leastalong the length of the trough 120 of the shaft 104. The distal ends ofthe cutting portion 872 and of the collecting portion 874 may berejoined or may remain separate. The membrane 114 may define a lumen inwhich the free end of the collecting portion 874 may be introduced.Alternatively, the membrane 114 may be wrapped around the collectingportion 874 and secured thereto by means of an adhesive. The cuttingportion 872 of the single ribbon 876 forms the leading edge of theintegrated cut and collect assembly 108 as the device is rotated withinthe tissue and the specimen cut from the surrounding mass of tissue.

[0087]FIG. 8E shows another exemplary configuration of the integratedcut and collect assembly 108 of the present invention. The top figure ofFIG. 8E shows the integrated cut and collect assembly 108 in theretracted position whereas the bottom figure shows the integrated cutand collect assembly 108 in the expanded position. As shown in the topfigure, the membrane 114, when the integrated cut and collect assembly108 is in the retracted position, is stretched across the trough 120. Inthis embodiment, the cutting portion of the integrated cut and collectassembly 108 may include a cutting ribbon 116 that emerges through themembrane 114 through a first slit therethrough and returns to the trough120 through a second slit or opening defined therethrough. The cuttingribbon 116, therefore, is configured to be exposed to the tissue to becut when the device is inserted within the patient and is located on afirst external-facing surface of the membrane 114. The collectingportion of the integrated cut and collect assembly 108 may also includea collecting ribbon 118 that is located on a second surface of themembrane 114. The membrane may be attached to the shaft 104 such thatwhen the integrated cut and collect assembly 108 is expanded in theradial direction relative to the shaft 104, the collecting ribbon 118stretches the membrane 114 and causes the bag-shaped membrane 114 todefine the mouth 222 (see FIG. 2C) of the collecting portion. Afteropening of the mouth or opening 222 by expansion of the integrated cutand collect assembly 108 and the stretching of the membrane 114 andafter tissue has been collecting in the membrane 114, the integrated cutand collect assembly 108 may be retracted at least partially within thetrough 120, causing the membrane 114 to return to the configurationshown in the top drawing of FIG. 8E. That is, the membrane 114 stretchesback over the trough 120, thereby at least partially isolating thecollected specimen from the surrounding tissue. In this embodiment, thecollecting ribbon 118 may not be attached to the membrane 114. Indeed,the collecting ribbon 118 may only act upon the membrane 114 to stretchthe membrane 114 open by pushing on it in the radial direction. When thespecimen has been collected and the integrated cut and collect assemblyintegrated cutting and collecting assembly 108 retracted at leastpartially within the trough 120, the resilient nature of the membrane114 causes the membrane to stretch back over the trough 120.

[0088] The foregoing has detailed a number of exemplary embodiments ofthe integrated cut and collect assembly 108. Those of skill in the art,however, may devise other alternative configurations and structures tointegrate the cutting and collecting functions of reference numeral 108into a single, mechanically coupled assembly that is actuable by asingle actuator, such as shown at 112. All such alternativeconfigurations, however, are deemed to fall within the purview of thepresent invention.

[0089]FIGS. 9-16 show aspects of the present method for isolating atissue specimen from surrounding tissue, according to embodiments of thepresent invention. As shown in FIG. 9, the excisional device 100according to an embodiment of the present invention may be insertedthrough the skin 902 (or through the outermost tissue surface of themass or organ from which the specimen is to be collected), either bymaking a prior incision therein or by allowing the distal tip 106 of thedevice 100 to make the initial cut. The distal tip 106 may be energizedwith RF energy during the insertion of the device 100 into the mass oftissue 908, but need not be. Satisfactory results are obtained byequipping the distal tip 106 with sharp blades and a conical shape,without the need for an RF energized tip. The integrated cut and collectassembly 108 should be initially in the retracted position, to enable itto readily penetrate the mass of tissue and advance to the target area(in this exemplary case, lesion 904) with the smallest possible profile.The shaft 104 may then be advanced (either through manual physiciancontrol or by means of a stereotactic setup) to a position wherein theintegrated cut and collect assembly 108 is adjacent the target 904 andthe target is approximately positioned in the middle of the integratedcut and collect assembly 108. As shown in FIG. 10, when the integratedcut and collect assembly 108 of the device 100 is positioned adjacentthe target lesion 904, the integrated cut and collect assembly 108 maybe expanded in the direction indicated by 110 by acting upon theactuator 112, after having fully energized the integrated cut andcollect assembly 108 with RF energy, preferably while the integrated cutand collect assembly 108 is at least partially retracted within thetrough 120. The integrated cut and collect assembly 108 may be expandedto up to its maximum expansion or to a selectable degree of expansion,advantageously under real time ultrasonic guidance and/or under anotherimaging modality. As shown at FIG. 11, the present excisional device 100may then be rotated in the direction indicated by arrow 1102, while theintegrated cut and collect assembly 108 remains energized with RFenergy. In this manner, the leading edge of the RF-energized integratedcut and collect assembly 108 cuts through the tissue. Preferably theintegrated cut and collect assembly 108 is expanded to a sufficientdegree so as to cut a margin of healthy tissue around the target lesion904, so as to decrease the probability of seeding abnormal cells (e.g.,cancerous or pre-cancerous) into and around the excision site and theretraction path. As shown in FIG. 11, as the energized integrated cutand collect assembly 108 is rotated, it cuts around the lesion 904. Asthe trailing edge of the integrated cut and collect assembly 108 hasdeployed the collecting portion thereof, the cut lesion or specimen 904is collected in the open bag formed by the trailing and close endedflexible membrane 114. As shown in FIGS. 12 and 13, the rotation 1102 ofthe device 100 may be continued as needed (preferably under ultrasonicguidance) until the specimen 904 has been at least partially severedfrom the surrounding tissue 906. At this point, the specimen 904 hasbeen at least partially collected within the bag-shaped flexiblemembrane 114 of the collecting portion of the integrated cut and collectassembly 108. As shown at FIG. 14, to fully sever the specimen 904 fromthe surrounding tissue 906, the integrated cut and collect assembly 108,while still RF energized, may be retracted by acting proximally upon theactuator 112, thus causing the integrated cut and collect assembly 108to move in the direction 1104 to capture and encapsulate the specimen904 within the flexible membrane 114. As the bag-shaped flexiblemembrane is now closed, the cut and collected specimen is effectivelyisolated and encapsulated (or substantially isolated and encapsulated)from the surrounding tissue 906. Indeed, the cut and collected specimen904 is now separated from the surrounding tissue by a layer of theflexible membrane 114. The RF to the integrated cut and collect assembly108 may now be turned off.

[0090] As shown in FIG. 14, the cut, collected, encapsulated andisolated specimen 904 may then be recovered by retracting the device 100from the mass of tissue 908 by moving the device 100 along the directionindicated at 1106. As shown in FIG. 14, the material of the flexiblemembrane 114 may be sufficiently elastics so as to allow the cut,collected and physically isolated specimen to stretch so as to at leastpartially trail the distal tip 106 as the device 100 is retracted alongthe insertion path through the mass of tissue 908, as shown at 1502 inFIG. 14. By configuring the integrated cut and collect assembly 108 soas to allow the specimen filled bag-shaped flexible membrane 114 totrail the distal tip 106, the initial incision into the skin and thediameter of the insertion and retraction path may be kept small, asneither the retraction path nor the incision need accommodate the fullaggregate width of the shaft 104, the integrated cut and collectassembly 108 and the isolated specimen 904.

[0091] As shown in FIG. 154, the specimen-filled flexible membrane ofthe collecting portion of the integrated cut and collect assembly 108may be configured so that it does not substantially trail the distaltip, or only does so partially during retraction of the device 100 fromthe mass of tissue from which the specimen was cut. The material of theflexible membrane 114 (as detailed below) and the configuration thereofmay be chosen so as to achieve the desired behavior during thecollecting, isolating and retracting phases of the present method. FIG.16 shows a fully retracted device 100, containing a collected andisolated specimen 904 in which the tissue architecture has beenmaintained substantially intact. After full retraction of the device 100from the mass of tissue, the incision within the skin 904 may be treatedand closed according to standard surgical practices. During theexcisional method detailed relative to FIGS. 9-16, the second lumen 206(shown in FIG. 2A) within the shaft 104 may be used, for example, toevacuate smoke and/or bodily fluids (e.g., blood) from the excision sitewithin the mass of tissue 908. Alternatively the second lumen 206defined within the shaft 104 may be used to deliver a pharmaceuticalagent to the excisional site, such as, for example, an anesthetic, ananalgesic and/or some other agent. The inflatable balloon 208 shown inFIG. 2A may be may be inflated with, for example, a gas (air or carbondioxide, for example) or a fluid (such as saline, for example). Theballoon 208 may assist in stabilizing the present excisional devicewithin the tissue mass after insertion therein and/or to provide somedegree of hemostasis during the excisional procedure.

[0092] The flexible membrane 114 is preferably non-conductive and stableat high temperatures. For example, the material used in the flexiblemembrane should be RF resistant (i.e., have the ability to withstand thetemperatures generated by the RF-energized cutting portion of theintegrated cut and collect assembly integrated cutting and collectingassembly 108). The flexible membrane 11, therefore, should be stable(i.e., acceptably maintains its structural integrity and does notunacceptably melt, deform, burn or loose cohesion, tensile or shearstrength) at temperatures at which the energized cutting portionoperates. According to one embodiment of the present invention, theflexible membrane includes a non-main chain carbon based polymericmaterial, such as a silicone elastomer (such as polydimethylsiloxane,for example) or a silicone-containing elastomer. For example, theflexible membrane 114 of the collecting portion of the integrated cutand collect assembly 108 may include one or more of the followingmaterials: an organic, inorganic or organic-inorganic polymer such as asilicone elastomer or a silicone-containing elastomer, a teraphthalate,a tetrafluoroethylene, a polytetrafluoroethylene, a polyimid, apolyester, a polyolephin, Kevlar® and/or M5®, for example. The flexiblemembrane 114 may have a laminar structure that includes one or morereinforcing layers. Such reinforcing layers may include, for example,any of the above-listed materials and/or polyester, polyurethane orpolyimid, for example. For example, the flexible membrane 114 mayinclude NuSil 10-6640, a material manufactured by NuSil Technology ofCarpinteria, Calif. The thickness of the flexible membrane may be freelychosen according to the desired characteristics of the collectingportion of the integrated cut and collect assembly 108. For example, theflexible membrane 114 may be between about 0.0005 and about 0.1 inches,for example. For example, the flexible membrane 114 may be chosen tohave a thickness between about 0.0007 and 0.005 inches. For example, theflexible membrane 114 may be selected to have a thickness of between0.001 and 0.015 inches.

[0093] When an adhesive is used to secure the flexible membrane to otherstructures of the device or the integrated cut and collect assembly 108,a strong, biologically inert and safe adhesive may be used.Advantageously, a silicone containing or based adhesive or acyanoacrylate containing or based adhesive may be used with goodresults.

[0094]FIG. 17 shows a device for collecting a specimen from a mass oftissue, according to another embodiment of the present invention. Asshown therein, the device includes a shaft 1704 that defines a proximalend (adjacent the handle) and a distal end (at the free end of the shaft1704). A specimen collection assembly 1710 is disposed near the distalend of the shaft 1704. The specimen collection assembly 1710 may includea flexible membrane 114 configured to collect the specimen, as detailedabove. The specimen collection assembly 1710 may also include a tissuecutting assembly, as detailed above. According to the embodiment of thepresent invention illustrated in FIGS. 17 and 18, the device may alsoinclude a specimen management assembly that is coupled to the specimencollection assembly 1710. The specimen collection assembly 1710 isconfigured to assume a variable expanded configuration as shown in FIG.17 and a retracted configuration shown in FIG. 18. In use, the specimenmanagement assembly is configured to draw the specimen collected in theflexible membrane 114 toward the shaft 1704. By drawing the specimen 904collected in the flexible membrane 114 toward the shaft 1704 when thespecimen collection assembly 1710 is in its retracted position (FIG.18), the specimen 904 may be compressed and/or may be elongated withinthe flexible membrane and along the shaft 1704. This compression and/orelongation may streamline the profile of the specimen collectionassembly 1710 and enclosed specimen 904. In turn, a more streamlinedprofile may ease the retraction of the device from mass of tissue inwhich it was inserted and from the patient without necessitating a largeincision or enlarging the incision made to insert the device. In theembodiments shown in FIGS. 17 and 18, the specimen management assemblyis coupled to the flexible membrane 114 of the specimen collectionassembly 1710. Any structure that draws the specimen 904 toward theshaft 1704, however, may be used and falls within the scope of thepresent invention. For example, and as shown in FIGS. 17 and 18, thespecimen management assembly may configured to selectively pull on theflexible membrane 114 in at least one direction that is parallel to theshaft 1704—i.e., toward the proximal end of the shaft 1704 and/or towardthe distal end of the shaft 1704. Indeed, by pulling on the flexiblemembrane 114 when the specimen collection assembly 1710 is in itsretracted state (FIG. 18), the specimen 904 may be somewhat compressedby the flexible membrane 114 in a direction that is generallyperpendicular to the longitudinal axis of the shaft 1704 and/or somewhatelongated in a direction that is parallel to the longitudinal axis ofthe shaft 1704. For example, the specimen management assembly may, forexample, pull the flexible membrane 114 toward the distal end of theshaft 1704. Alternatively, the specimen management assembly may, forexample, pull the flexible membrane 114 toward the proximal end of theshaft 1704, as shown in FIGS. 17 and 18.

[0095] As shown therein, one or more wires 1708 may be attached to theflexible membrane 114. Within the context of the present invention, theterm “wire” is to be interpreted broadly and is intended to encompassstructures such as cables, strings, filaments, threads, cords, ribbonsas well as structures such as fabrics, meshworks, lattices and the like.The wire(s) 1708 may be formed of any strong and surgically suitablematerial that may attach to the flexible membrane 114, such as, forexample, Kevlar® or M5® material. The distal ends of the wires 1708 maybe attached to various points on the flexible membrane 114. The proximalend of the wires 1708 may be attached to an actuator, such as shown at1720. In this manner, when the actuator 1720 is pushed distally, thespecimen collection assembly may assume its expanded configuration shownin FIG. 17 and the wires 1708 may be loose. Conversely, when theactuator 1720 is pulled proximally (as shown in FIG. 18), the wires 1708may be tightened and pull on the flexible membrane 114. Alternatively,the proximal end o the wires 1708 may be coupled to a wire actuator (notshown) that may be separate and distinct from the actuator 1720.

[0096] As noted above, during the collection of the specimen 904 (FIG.17), the wire or wire(s) 1708 are preferably loose and preferably do notpull on the flexible membrane 114. After the specimen 904 has beencollected (FIG. 18) and isolated within the flexible membrane 114 fromthe surrounding tissue by retracting the specimen collection assembly,the wires 1708 may pull on the flexible membrane 114 to reduce theradial height of the collected specimen 904 over the shaft 1704, asshown in FIG. 18. In FIG. 18, the wires 1708 are taut and pull on theflexible membrane 114, thereby somewhat compressing and/or elongatingthe specimen 904. As shown, the wires 1708 may run within a lumendefined within the shaft 1704 and may emerge to attach to the flexiblemembrane through a bore 1706 defined between the interior lumen of theshaft 1704 and the external surface thereof. The wires 1708 may insteadbe attached to the distal portion of the flexible membrane 114, travelto the distal end of the shaft 1704 and back to the actuator 1720. Forexample, the wires 1708 may slide over a pin disposed within the distalend of the shaft 1704. Alternatively still, either the distal orproximal portions of the flexible membrane 114 may be attached to theshaft 1704 while the wires 1708 may be attached to the other one of thedistal and proximal ends not attached to the wires 1708. In this manner,one side or portion of the flexible membrane 114 may be anchored to theshaft 1704 and the other side or portion pulled by the wires 1708. Forexample, as shown in FIGS. 17 and 18, the distal portion of the flexiblemembrane 114 may be attached to the shaft 1704 while the proximalportion of the flexible membrane 114 may be selectively and variablypulled by the wires 1708 to draw the specimen 904 toward the shaft 1704,to thereby reshape the flexible membrane 904 and the collected specimen904. This effectively reduces the resistance of the entire device withinthe tissue and makes it easier to maneuver the device within the tissue.More particularly, the reshaped flexible membrane 114 and collectedspecimen 904 eases the retraction of the device back through thedissection (entry) path and through a smaller incision that wouldotherwise be possible had the flexible membrane 114 and the specimencollected therein maintained their original profile.

[0097]FIGS. 19 and 20 show aspects of another embodiment of the presentinvention. As shown therein, instead of wires, ribbons or cords 1708,the flexible membrane 114 itself may be pulled in the proximal and/ordistal directions to draw the collected specimen 904 toward the shaft1704. One end of the flexible membrane 114 may be secured to the shaft1704. The flexible membrane may include an extension that runs through abore 1706 to a lumen within the shaft 1704, to the actuator 1720 oranother independent actuator (not shown). Alternatively still, theflexible membrane extension may be attached to one or more wires 1708that run to an actuator, as described above. This embodiment isfunctionally similar to the embodiment of FIGS. 17 and 18, as thecollected specimen 904 is drawn toward the shaft 1704 by similarlydirected forces.

[0098] The wires, ribbons or cords 1708 advantageously also operate tore-shape the tract from the incision to the cavity created by thecollected specimen. Indeed, the wires, ribbons or cords 1708 cause thecollection assembly 1710 containing the specimen 904 to present a moretapered profile as the device is retracted from the patient. The shapeof the flexible membrane bag 114 in FIGS. 19 and 20 also presents atapered profile that eases the retraction of the device from the tractafter the specimen 904 has been cut, collected and shaped.

[0099]FIGS. 21-23 illustrate aspects of another embodiment of thepresent invention. More particularly, FIGS. 21-23 show the distalportion of the shaft 1716 of a tissue collection device according toanother embodiment of the present invention. The proximal portionthereof is not shown in FIGS. 21-23, for clarity of illustration. Asshown, the shaft 1716 may define a channel 1718 along at least a portionof its length. The specimen collection assembly 1710 is free toselectably slide within the channel 1718 from the proximal end thereofthe distal end thereof. When the device is initially inserted in thepatient, the specimen collection assembly 1710 and attached flexiblemembrane 114 may be proximally retracted, so as to provide the leastamount of resistance with the surrounding tissue during the insertion.Thereafter, when the distal portion of the shaft 1716 has beenmaneuvered adjacent the target lesion or other tissue to be collected,biopsied or otherwise excised, the specimen collection assembly 1710 andattached flexible membrane may be distally slid and more or lesscentered on the target lesion, under ultrasonic guidance, for example.As shown in FIG. 21, the specimen collection assembly 1710 may then becaused to assume its expanded configuration shown.

[0100] In the case wherein the specimen collection assembly 1710includes a specimen cutting assembly (such as an RF cutter, forexample), the shaft 1716 may be rotated and the target lesion severedfrom the surrounding tissue to create the specimen as detailed above. Inso doing, the flexible membrane 114 may be deployed and encapsulate thecreated specimen. In the case wherein the tissue collection specimendoes not include a specimen cutting assembly and the specimen hasalready been created (i.e., the target lesion severed from surroundingtissue) but has not but not yet collected, the tissue specimencollection assembly 1710 may be expanded, rotated and retracted to theconfiguration shown in FIG. 22 to collect and isolate the specimen 904from the surrounding tissue within the flexible membrane 114.

[0101] The devices according to the embodiments of the present inventiondescribed herein, however, may cut and collect tissue specimens 904 thatare larger than the initial incision made in the patient to introducethe device in the patient. To avoid having to enlarge the incisionand/or the retraction path of the device and to prevent such incisionfrom tearing or stretching during withdrawal of the collected andisolated specimen 904, it may necessary to streamline or otherwise alterthe shape of the specimen collected within the flexible membrane 114.This may reduce its profile and facilitate withdrawal of the device andcollected specimen from the patient. To do so, the specimen collectionassembly 1710 containing the collected specimen 904 may be slid withinthe channel 1718 in the proximal direction, as shown in FIG. 23. As aportion (the distal portion, for example) of the flexible membrane maybe attached (either directly or through other structures) to the distalend of the shaft as shown at 1721, the flexible membrane 114 and thecollected and isolated specimen 904 will be drawn against the shaft1716, thereby forming a slimmer profile and easing the removal of thedevice from the patient. Indeed, as the specimen collection assembly1710 and the attached flexible membrane 114 is retracted in the proximaldirection while a portion of the flexible membrane remains attached tothe distal end of the shaft 1716, the flexible membrane 114 will tightenaround the collected specimen 904, thereby drawing it closer to theshaft 1716, somewhat compressing and/or elongating the specimen 904 inthe process. Instead of or in addition to the channel 1718, the specimencollection assembly 1710 may slide in the proximal and distal directionson a rail running along the shaft 1716. The embodiment of FIGS. 21-23may be used in conjunction with some or all of the structures shown anddescribed relative to FIGS. 17-20. Other means of drawing a collectedspecimen toward the shaft and/or reshaping the collected specimen toease retraction of the collection device may occur to those of skill inthis art and all such variations are deemed to fall within the scope ofthe present invention.

[0102]FIG. 24 is a perspective view of a distal portion of the shaft ofan excisional device in a first configuration, according to a sillfurther embodiment of the present invention. FIG. 25 shows theembodiment of FIG. 24, with the shaft represented in phantom (dashed)lines to reveal further structural aspects of this embodiment.Similarly, FIG. 26 is a perspective view of a distal portion of theshaft of the excisional device of FIGS. 24 and 25 in a secondconfiguration. FIG. 27 shows the embodiment of FIGS. 24-26, with theshaft represented in phantom lines to reveal exemplary internalstructure. Considering now FIGS. 24-27 collectively, the shaft 1716 maydefine a channel or other opening 1718 and the specimen collectionassembly 1710 may be configured to selectively slide between theproximal end and distal ends of the shaft 1716. The channel 1718 may bedefined from the distal end of the shaft 1716 to the proximal endthereof, or only a portion of the distance therebetween. In FIGS. 24 and25, the specimen collection assembly 1710 is in its first configuration,closer to the proximal end of the shaft 1716 than to the distal endthereof. Conversely, FIGS. 26 and 27 show the present excisional devicein a second configuration in which the specimen collection assembly 1710is closer to the distal end of the shaft 1710 than to the proximal endthereof. To ease insertion of the shaft 1716 into the patient, the shaftmay be inserted into the patient in the first configuration in which thespecimen collection assembly 1710 is in the first configuration shown inFIGS. 24 and 25. That is, prior to inserting the shaft 1716 into thepatient, the physician may slide the specimen collection assembly 1710at least partially along the channel 1718 in the proximal direction, soas to present smoother profile as the device is inserted into thetissue.

[0103] The distal tip of the shaft 1716 of the embodiments shown inFIGS. 17-29 may have any suitable configuration that is effective topenetrate and maneuver the shaft 1716 within tissue. The distal tip may,for example, have a sharp edge, may have an RF-powered element or mayhave any other surgically suitable structure. FIGS. 17-27 genericallyshow the distal tip as a blunt surface, for ease of illustration only.

[0104] When the excisional device according to the embodiment of FIGS.24-27 has been positioned adjacent or near the target lesion orspecimen, the specimen collection assembly 1710 may be slid in thedistal direction so as to cause the excisional device to assume theconfiguration shown in FIGS. 26-27. Moreover, after the specimen hasbeen collected within the flexible membrane 114, the specimen collectionassembly 1710 may again be slid from the distal end of the shaft 1716toward the proximal end thereof, if desired (before, during or after thephysician retracts the device along the dissection or retraction path).In addition, the collected specimen may be drawn toward the shaft 1716,as described herein relative to FIGS. 17-23 or by other means. While thespecimen 904 is being drawn toward the shaft 1716 and while the specimencollection assembly 1710 is being slid toward the proximal direction,the specimen 904 remains encapsulated by the flexible membrane 114 andisolated from the surrounding tissue, to minimize or eliminate thechance of seeding potentially abnormal cells (e.g., cancerous cells) inthe retraction path of the excisional device or in any of thesurrounding tissue.

[0105]FIGS. 25 and 27 show the shaft 1716 in phantom lines to revealexemplary internal structure of the excisional device according to thisembodiment of the present invention. The specimen collection assembly1710 may be configured to selectively slide between a proximal position(FIGS. 24-25) and a distal position (FIGS. 26-27) by various means. Asshown in FIGS. 25 and 27, the distal end of the specimen collectionassembly 1710 may be coupled to a slider 1722. The slider 1722 may beconfigured to slide within the shaft 1716. The travel of the slider 1722in the distal direction may be limited by abutting against the distalend 1728 of the shaft 1716. To slide within the shaft 1710, the slider1722 may be attached to a flexible wire 1720. The wire 1720 may berouted to the distal end of 1728 of the shaft 1716 via a through boredefined in the distal end 1728 and thereafter back to a suitableactuator on the proximal end 102 (the handle) of the present excisionaldevice. In that case, pulling on the wire 1720 causes the slider 1722 toslide within the shaft 1716 in the distal direction. The wire 1720 maybe partially external to the shaft 116 as shown in FIGS. 24-27 or may beentirely accommodated within the shaft 1716. To retract the slider 1722and the specimen collection assembly 1710 in the proximal direction, thephysician may cause the specimen collection assembly 1710 to assume itsretracted position (FIGS. 24-25) in the manner described above and maythereafter further pull on the specimen collection assembly 1710 in theproximal direction, thereby causing the cutting and/or collectingribbon(s) thereof to pull the attached slider 1722 in the proximaldirection.

[0106] Alternatively (or in addition to the wire 1720), the slider 1722may also be coupled to a rigid member 1724 within the shaft 1716. Inthat case, sliding the slider 1722 within the shaft 1726 may beaccomplished by pushing or pulling on the rigid member 1724. Sliding theslider 1722 in the distal direction, therefore, may rely on the columnstrength of the rigid member 1724. The shaft 1716 may also accommodatean internal cannula 1726. The cannula 1726 may be movable within theshaft 1716. During use of the excisional device, the cannula 1726 maycooperate with the slider 177 to position the specimen collectionassembly 1710 adjacent the specimen to be cut and/or collected. Theproximal portions of the cutting and/or collection ribbons of thespecimen collection assembly 1710 as well as the proximal portion of therigid member 1724 may be disposed within an internal lumen of thecannula 1726, as shown in FIGS. 25 and 27. The distance along thelongitudinal axis of the shaft 1716 between the slider 1722 and thecannula 1726 defines the distance over which the specimen collectionassembly 1710 may bow (as shown in FIGS. 26 and 27). Toward that end,the cannula 1726 may itself slide within the shaft 1716, as may be seenby comparing the relative positions of the cannula 1726 in FIGS. 25 and27. In use, the combination of the slider 1722, the rigid member 1724,the cannula 1726 and the specimen collection assembly 1710 may be slidall the way in the proximal or distal directions or may be locked in anintermediate position therebetween and the specimen collection assembly1710 expanded in such a locked position. Suitable actuators may bedisposed on the proximal end 102 (the handle) of the present excisionaldevice to effectuate such sliding and/or locking functions. Of course,other mechanisms and assemblies for sliding the specimen collectionassembly 1710 within a channel 1718 may be devised, as those of skill inthis art may recognize. As noted above, the embodiments shown anddescribed relative to FIGS. 17-23 may be implemented in combination withthe embodiment shown in FIGS. 24-27 to draw the collected specimentoward the shaft 1716 to ease retraction of the device from the patientafter the specimen 904 has been collected. To enable the flexiblemembrane 114 of the specimen collection assembly 1710 to slide betweenproximal and distal positions within the shaft 1716, the flexiblemembrane 114 may advantageously be attached to the rigid member 1724 aswell as to the collection ribbon of the specimen collection assembly1710. In this manner, the flexible membrane 114 may form a bag shapewhose opening is defined by the rigid member 1724 and the collectionribbon of the specimen collection assembly 1710. When the specimencollection assembly 1710 is in its retracted or collapsed configuration(FIGS. 24-25), the opening of the bag-shaped flexible membrane 114 isclosed, thereby substantially sealing the collected specimen 904therein. Indeed, when the specimen collection assembly 1710 is in itsretracted configuration, the collection ribbon to which the flexiblemembrane 114 is attached is in a position that is adjacent the rigidmember 1724 to which the flexible membrane 114 is also attached, therebyeffectively closing the bag-shaped flexible membrane 114 and isolatingthe collected specimen within the flexible membrane.

[0107] According to another embodiment, the distal end 1728 of the shaft1716 may be open and the shaft 1716 may be removable (i.e., detachable)from the handle of the device. In that case, after the tissue or lesionhas been cut and collected, the shaft 1716 may be detached from thehandle of the device and slid in the proximal direction, leaving thecollection assembly 1710 in place within the patient. The collectionassembly may then be separately removed. Detaching the shaft 1716 fromthe device prior to retraction of the collection assembly 1710 may easethe retraction of a large specimen through the incision by allowing thecollection assembly to occupy the space previously occupied by the shaft1716. Alternately, the channel 1718 and the collection assembly may beconfigured so as to enable the collection assembly to be slid proximallyout through the incision and removed from the shaft 1716. The channel1716 may thereafter be used as a guide to introduce other items into thelesion or specimen cavity, such as a balloon to stop bleeding, a markeror an endoscope, for example.

[0108]FIG. 28 is a cross-sectional view of the shaft of anotherembodiment of the present invention. According to this embodiment, atleast a portion of the shaft 1716 is covered by a sleeve, to ease theinsertion and/or retraction of the present excisional device into andfrom a mass of tissue. FIG. 29 is a cross-sectional view of theembodiment of FIG. 28, with the specimen collection assembly of thepresent excisional device in an expanded configuration. In thisembodiment, the shaft is designated by reference numeral 1716, theflexible membrane by reference numeral 114 and the collection ribbon ofthe specimen collection assembly by reference numeral 2806. The specimencollection assembly may also include a cutting ribbon, shown in phantomlines at reference numeral 2804. The collection ribbon and the cuttingribbon may be attached to one another or may be independently actuable.According to this embodiment, a sleeve 2802 covers at least a portion ofthe circumference and length of the shaft, such as shaft 1716 in FIGS.24-27. Such a sleeve 2802 may ease at least the insertion of the shaft1716 into the patient's tissue. According to one embodiment, the sleeve2802 may be retracted prior to the specimen collection assembly beingexpanded and the device rotated to collect a previously cut specimen orto cut and collect a specimen from a surrounding mass of tissue.According to another embodiment and as shown in FIGS. 28 and 29, awindow or cutout may be defined within the sleeve in such a manner as toalign with the channel 1718 and/or otherwise allow the expansion andretraction of the specimen collection assembly in the radial direction.The window or cutout defined within the sleeve 2802 may also allow thespecimen collection assembly to slide in the proximal and distaldirections, in the manner described relative to FIGS. 24-27, forexample. According to an embodiment of the present invention, to furtherreduce the drag of the flexible membrane against the tissue duringinsertion of the excisional device into the patient's tissue and themanipulation thereof to bring the shaft 1716 in adjacency with thetarget lesion or specimen to be collected or cut and collected, theflexible membrane 114 may be initially at least partially stowed betweenan internal surface of the sleeve 2802 and an external surface of theshaft 1716, as shown in FIGS. 28 and 29. As shown therein, the flexiblemembrane 114 may be wrapped around the outer surface of the shaft, withthe sleeve 2802 fitting over the flexible membrane 114. FIG. 28 showsthe flexible membrane attached at one end to a membrane support 2808 andthereafter running between the sleeve and the shaft 1716 at leastpartially around the circumferences thereof. As shown the flexiblemembrane 114 may then double back upon itself, and may thereafter attachto, for example, the collection ribbon 2806 of the specimen collectionassembly. As shown this end of the flexible membrane 114 may wrap aroundthe tissue collection ribbon 2806. The specimen collection assembly mayalso include a cutting ribbon (shown in phantom line) 2804, which may beindependent from the collection ribbon 2806 or coupled thereto, asdescribed previously herein.

[0109] When the specimen collection assembly is expanded (e.g., bowed inthe radial direction), the collection ribbon 2806 bows radially awayfrom the shaft 1716 and may assume the configuration shown in FIG. 29.As shown therein, the collection ribbon 2806 pulls on the flexiblemembrane initially stowed between the shaft 1716 and the sleeve 2802. Asthe collection ribbon 2806 rises, the flexible membrane 114 is at leastpartially pulled out of its stowed configuration and follows thecollection ribbon 2806. As the present excisional device is then rotatedand the specimen collected (or cut and collected), more or all of theflexible membrane 114 may be pulled from between the shaft 1716 and thesleeve 2802. Advantageously, the flexible membrane 114 does not generateincreased friction against the tissue during insertion of the deviceinto the patient's tissue and/or during the fine displacements of theshaft 1716 that may be required to precisely locate the distal portionthereof adjacent to target tissue to be collected and/or excised andcollected. Also, because the flexible membrane 114 is pulled frombetween the shaft 1716 and the sleeve 2804 when the collection assemblyis deployed, it is unlikely to interfere with the RF cutting of thecutting ribbon 2804. Indeed, in this configuration, the flexiblemembrane is unlikely to fold against the leading (e.g., cutting) edge ofthe cutting ribbon 2804. Moreover, the rotation of the device (forexample, counterclockwise in FIGS. 28 and 29, may insure that theflexible membrane always trails behind the cutting ribbon 2804, therebyinsuring that both the cutting and collecting operations occur withoutinterference from the flexible membrane as it is deployed and pulledfrom between the sleeve 2804 and the shaft 1716.

[0110] While the foregoing detailed description has described preferredembodiments of the present invention, it is to be understood that theabove description is illustrative only and not limiting of the disclosedinvention. For example, those of skill in this art may envisage othermeans of reducing drag and/or re-shaping the collected specimen prior toretraction of the present and like devices from the patient's tissue.Indeed, those of skill in this art will recognize other alternativeembodiments and all such embodiments are deemed to fall within the scopeof the present invention. Thus, the present invention should be limitedonly by the claims as set forth below.

What is claimed is:
 1. A device for collecting a specimen from a mass oftissue, comprising: a shaft defining a proximal end and a distal end; aspecimen collection assembly disposed near the distal end, the specimencollection assembly including a flexible membrane configured to collectthe specimen; a specimen management assembly, the specimen managementassembly being coupled to the specimen collection assembly andconfigured to draw the specimen collected in the flexible membranetoward the shaft.
 2. The device of claim 1, wherein the flexiblemembrane is configured to isolate the collected specimen from a mass oftissue surrounding the specimen.
 3. The device of claim 1, wherein thespecimen management assembly is coupled to the flexible membrane.
 4. Thedevice of claim 3, wherein the specimen management assembly isconfigured to selectively pull on the flexible membrane in at least onedirection that is parallel to the shaft.
 5. The device of claim 4,wherein the specimen management assembly is configured to selectivelypull on the flexible membrane both toward the distal end of the shaftand toward the proximal end of the shaft.
 6. The device of claim 4,wherein the specimen management assembly is configured to selectivelypull on the flexible membrane only toward the distal end of the shaft.7. The device of claim 4, wherein the specimen management assembly isconfigured to selectively pull on the flexible membrane only toward theproximal end of the shaft.
 8. The device of claim 7, wherein a portionof the flexible membrane is attached to the distal end of the shaft. 9.The device of claim 1, wherein the specimen management assembly includesat least one wire coupled to the flexible membrane.
 10. The device ofclaim 9, wherein the at least one wire is configured to selectively pullon the flexible membrane in at least one direction that is parallel tothe shaft.
 11. The device of claim 9, wherein the at least one wire isconfigured to selectively pull on the flexible membrane both toward thedistal end of the shaft and toward the proximal end of the shaft. 12.The device of claim 9, wherein the at least one wire is configured toselectively pull on the flexible membrane only toward the distal end ofthe shaft.
 13. The device of claim 9, wherein the at least one wire isconfigured to selectively pull on the flexible membrane only toward theproximal end of the shaft.
 14. The device of claim 13, wherein a portionof the flexible membrane is secured to the distal end of the shaft. 15.The device of claim 9, further including a specimen cutting assembly,the specimen cutting assembly being configured to cut the specimen froma mass of tissue.
 16. A method of collecting a specimen from a mass oftissue, comprising the steps of: providing a tissue collection devicecomprising a shaft having a proximal and a distal end; a specimencollection assembly disposed near the distal end, the specimencollection assembly including a flexible membrane configured to collectthe specimen; inserting the tissue collection device within the mass oftissue; collecting the specimen within the flexible membrane, anddrawing the flexible membrane and the collected specimen toward theshaft.
 17. The method of claim 16, further including a step ofretracting the tissue collection device from the mass of tissue with thespecimen collected within the flexible membrane and drawn toward theshaft.
 18. The method of claim 16, wherein the tissue collection devicein the providing step includes a specimen management assembly coupled tothe flexible membrane and wherein the drawing step is carried out byacting on the specimen management assembly.
 19. The method of claim 18,wherein the specimen management assembly includes at least one wireattached to the flexible membrane.
 20. The method of claim 16, whereinthe collecting step isolates the collected specimen from a mass oftissue surrounding the specimen.
 21. The method of claim 16, wherein thedrawing step selectively pulls on the flexible membrane in at least onedirection that is parallel to the shaft.
 22. The method of claim 16,wherein the drawing step selectively pulls on the flexible membrane bothtoward the distal end of the shaft and toward the proximal end of theshaft.
 23. The method of claim 16, wherein the drawing step selectivelypulls on the flexible membrane only toward the distal end of the shaft.24. The method of claim 16, wherein the drawing step selectively pullson the flexible membrane only toward the proximal end of the shaft. 25.The method of claim 18, wherein the specimen management assemblyincludes at least one wire coupled to the flexible membrane and whereinthe drawing step includes pulling on the at least one wire.
 26. Themethod of claim 25, wherein the drawing step includes pulling on the atleast one wire in at least one direction that is parallel to the shaft.27. The method of claim 26, wherein the drawing step includes pulling onthe at least one wire both toward the distal end of the shaft and towardthe proximal end of the shaft.
 28. The method of claim 26, wherein thedrawing step includes pulling on the at least one wire only toward thedistal end of the shaft.
 29. The method of claim 26, wherein the drawingstep includes pulling on the at least one wire only toward the proximalend of the shaft.
 30. The method of claim 16, wherein the tissuecollection device in the providing step further includes a specimencutting assembly and wherein the method further includes a step ofacting upon the specimen cutting assembly to cut the specimen from themass of tissue.
 31. The method of claim 30, wherein the providing stepprovides the tissue collection device with the specimen cutting assemblycoupled to the specimen collection assembly.
 32. A device for collectinga specimen from a mass of tissue, comprising: a shaft; a specimencollection assembly configured to slide between the proximal and distalends of the shaft and to selectively assume an expanded configurationand a retracted configuration, the specimen collection assemblyincluding a flexible membrane configured to collect the specimen and toisolate the collected specimen from the mass of tissue.
 33. The deviceof claim 32, wherein a portion of the flexible membrane is attached tothe distal end of the shaft.
 34. The device of claim 32, wherein thespecimen collection assembly includes a cutting portion for cutting thespecimen from a surrounding tissue.
 35. The device of claim 32, whereinthe flexible membrane is configured to isolate the collected specimenfrom the mass of tissue.
 36. The device of claim 32, wherein the shaftdefines a proximal and a distal end and a channel between the proximaland distal ends and wherein the specimen collection assembly isconfigured to slide within the channel between the proximal and distalends of the shaft.
 37. The device of claim 32, wherein the shaft definesa proximal and a distal end and comprises a rail between the proximaland distal ends and wherein the specimen collection assembly isconfigured to slide on the rail between the proximal and distal ends ofthe shaft.
 38. A method of collecting a specimen from a mass of tissue,comprising the steps of: providing a tissue collection device comprisinga shaft and a specimen collection assembly, the shaft defining aproximal and a distal end, the specimen collection assembly beingconfigured to slide between the proximal and distal ends and toselectively expand away from the shaft and to contract toward the shaft,the specimen collection assembly including a flexible membraneconfigured to collect the specimen; inserting the tissue collectiondevice within the mass of tissue; expanding the specimen collectionassembly and collecting the specimen within the flexible membrane;retracting the specimen collection assembly with the specimen collectedwithin the flexible membrane; sliding the retracted specimen collectionassembly toward the proximal end of the shaft with the specimencollected within the flexible membrane.
 39. The method of claim 38,wherein the tissue collection device in the providing step includes atissue cutting portion to cut the specimen from the mass of tissue. 40.The method of claim 39, wherein the collecting step collects thespecimen cut from the cutting portion.
 41. The method of claim 38,further including a step of sliding the specimen collection assemblytoward the distal end of the shaft before the inserting step.
 42. Themethod of claim 38 wherein, in the inserting step, the tissue collectiondevice is in a configuration in which the specimen collection assemblyis slid toward the distal end of the shaft.
 43. The method of claim 38,further comprising a step of sliding the specimen collection assemblytoward the distal end of the shaft before the expanding and collectingsteps.
 44. The method of claim 38, wherein the tissue collection devicein the providing step is configured such that a portion of the flexiblemembrane is attached to the distal end of the shaft, and wherein thesliding step draws the specimen collected within the flexible membranetoward the shaft.
 45. The method of claim 38, further comprising thestep of retracting the tissue collection device from the mass of tissuewith the specimen collection assembly near the proximal end of the shaftand the specimen collected within the flexible membrane.
 46. The methodof claim 38, wherein the retracting step isolates the specimen collectedwithin the flexible membrane from the mass of tissue.
 47. The method ofclaim 38 wherein, in the providing step, the shaft defines a channelbetween the proximal and distal ends of the shaft and wherein thesliding step slides the retracted specimen collection assembly withinthe channel.
 48. The method of claim 38 wherein, in the providing step,the shaft includes a rail between the proximal and distal ends of theshaft and wherein the sliding step slides the retracted specimencollection assembly on the rail.
 49. A method of collecting a specimenfrom a mass of tissue, comprising the steps of: providing a tissuecollection device comprising a shaft defining a proximal and a distalend, a sleeve disposed over at least a portion of the shaft and aspecimen collection assembly configured to selectively expand away fromthe shaft and to retract toward the shaft and including a flexiblemembrane configured to collect the specimen, at least a portion of theflexible membrane being disposed between the shaft and the sleeve;inserting the tissue collection device within the mass of tissue;expanding the specimen collection assembly and collecting the specimenwithin the flexible membrane, the expanding specimen collection assemblypulling the flexible membrane out from between the shaft and the sleeve,and retracting the specimen collection assembly with the specimencollected within the flexible membrane.